A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

Study Identifier:
417-201-00042
ClinicalTrials.gov Identifier:
NCT06928142
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
844-687-8522 or [email protected]
Recruiting
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Study Details

Medical Condition
  • Autoimmune
Study Drug
  • Biological: Sibeprenlimab
Date
Apr 2025 - Mar 2027
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Diagnosed with Sjögren's disease.
  • ESSDAI score (which measures disease activity) must be 5 or higher.
  • Salivary flow rate must be at least 0.05 mL/min.
  • Serum IgG level must be higher than 900 mg/dL.
  • Must be able to communicate well with the investigator and agree to follow the trial requirements.
  • Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
  • Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
  • Test positive for anti-Ro52 and/or anti-Ro60 antibodies.
Exclusion Criteria
  • Another active autoimmune rheumatic disease.
  • Prior use of B-cell depleting therapy or prohibited immunosuppressants.
  • Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
  • Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

Protocol Summary

This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.

Study Locations

Location
Status
Location
Medvin Clinical Research - Riverside
Riverside, California, United States, 92508
Status
Recruiting
Location
Medvin Clinical Research - Tujunga
Tujunga, California, United States, 91042
Status
Recruiting
Location
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States, 33511
Status
Not yet recruiting
Location
Clinical Research of West Florida Inc
Clearwater, Florida, United States, 33765
Status
Recruiting
Location
GNP Research - Florida
Fort Lauderdale, Florida, United States, 33309
Status
Not yet recruiting
Location
Vantage Clinical Trials - Tampa - ClinEdge - PPDS
Tampa, Florida, United States, 33614
Status
Recruiting
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All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Diagnosed with Sjögren's disease.
  • ESSDAI score (which measures disease activity) must be 5 or higher.
  • Salivary flow rate must be at least 0.05 mL/min.
  • Serum IgG level must be higher than 900 mg/dL.
  • Must be able to communicate well with the investigator and agree to follow the trial requirements.
  • Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
  • Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
  • Test positive for anti-Ro52 and/or anti-Ro60 antibodies.
Exclusion criteria
  • Another active autoimmune rheumatic disease.
  • Prior use of B-cell depleting therapy or prohibited immunosuppressants.
  • Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
  • Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

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